Powered by innovation, we have established expertise across a broad range of CGT platforms:
mRNA is a promising and rapidly growing new type of advanced medicine with quick production speed, the ability to encode varied proteins, an excellent safety and efficacy profile, and flexibility in modality and formulation. We are able to provide end-to-end CRO (click here for mRNA CRO service) and CDMO services. Based on the well-established and high-efficient mRNA platform, we continue to acceralate your products from clinics to beyond.
At Porton Advanced, we have established an expert mRNA manufacturing process, including USP mRNA production (IVT, enzymatic/co-transcriptional capping poly(A) tailing, etc. with yield up to 10mg/mL), DSP mRNA purification (affinity chromatography, ion-exchange polishing, TFF, etc.) and lipid nanoparticle (LNP) delivery formulation. The validated process can greatly reduce the project timeline and deliver results with robust quality and high efficiency.
● Sequence design and optimization
● Supercoiled plasmid process development and cGMP production
● Linearized plasmid process development and cGMP production
● RNA (mRNA, saRNA, circRNA) process development and cGMP production
● LNP formulation development
● Analytical development
● QC release
● CMC information writing and regulatory submission
● Integrated IND-enabling Study Service
Porton Advanced’s Analytical platform utilized the CGE method for assessing mRNA integrity. Results showed a high level of mRNA intactness, meeting the process development standard.
Porton Advanced’s analytical platform showed the results on particle size distribution of LNP sample by SEC-MALS to be less than 0.1, proving the stable process delivered by the process development team.